Hospitals employ multiple strategies to prevent and/or reduce wound infections and infections associated with the use of percutaneous and drug delivery medical devices, such as antiseptic preparation of wounds and insertion sites. Such strategies include the initial application of topical antimicrobial solutions such as alcohol or iodine. Topical ointments, such as ointments containing neomycin, polymyxin and bactracin, and dressing devices have also been shown to prevent wound infections and catheter colonization/infection.
Many types of dressings are known for the treatment of wounds and insertion sites of percutaneous and drug delivery devices. Cuffs impregnated with an antimicrobial agent have been used to attach to catheters. Johnson & Johnson Corporation markets a commercially available cuff product sold under the trade mark BIOPATCH® that is applied around percutaneous devices to prevent localized infection at the insertion site. This product is a foam material that contains the antimicrobial agent chlorhexidine gluconate (CHG). Efforts to coat the catheters with antimicrobial agents are also known.
Recently transparent film dressings, that allow a visual check on a catheter insertion site, have been used as described in U.S. Pat. No. 5,372,589, issued Dec. 13, 1994 to Davis. Centurion Medical Products markets a commercially available catheter site dressing with antimicrobial properties sold under the trademark SorbaView® SHIELD. The 3M Company also markets a commercially available intravenous (IV) site transparent dressing sold under the trademark Tegaderm™-CHG (clorhexidine gluconate) that is designed to reduce the incidence of catheter-related bloodstream infections (CRBSI), with the CHG being the antimicrobial agent. The CHG is intended to elute from a pad that is transparent and covered with an adhesive bandage layer. The device, however, fails to provide 360 degree or complete circumferential coverage around the insertion site, and the CHG eluting portion of the device is not placed underneath the catheter which may further limit its effectiveness. The device transparency is also compromised when placed in an area with oozing blood and/or exudates.
Securement devices are also known, such as U.S. Pat. No. 3,918,446, issued Nov. 11, 1975 to Buttaravoli, that assist with keeping a percutaneous device in place. The device of U.S. Pat. No. 3,918,446 has an upper and a lower pad, between which the intravenous device is fixed. Since the function of the device is to secure the device to the body, there is a teaching to provide an adhesive material to the bottom of lower pad, and to the bottom of the top pad. U.S. Pat. No. 3,918,446 discusses providing the adhesive with an antibacterial agent, and the device of this patent teaches including a slit in the bottom pad of the dressing, which lies below the intravenous needle or catheter when the device is in place, allowing the intravenous device to remain in contact with the skin, and therefore limiting the infection control of the device.
U.S. Pat. No. 5,833,665 issued to Matthew Bootman et al. is directed to a wound dressing for percutaneous catheters that is comprised of a cross linked polymer containing a bioactive agent. U.S. Pat. No. 5,833,665 discloses a radial slit that is made in the device so that it can be deployed over an already placed catheter. It also discloses and claims the use of adhesives for securing the device.
U.S. Pat. No. 6,368,611 entitled “Anti-infective covering for percutaneous and vascular access device and coating method” and issued to Whitbourne discloses a device comprising a disc provided with an antimicrobial composition, wherein the composition comprises at least one antimicrobial agent exhibiting antimicrobial activity when in a substantially dry state or when solvated after being in a substantially dry state. The disc surrounds and abuts an inserted surface of an insertable medical device when a portion of the inserted surface projects from a bodily surface; the disc is in contact with the bodily surface.
In addition to infection control and transparency, there is a need for absorbent dressings to wick away blood and exudates. U.S. patent application Ser. No. 10/515,028 entitled “Ionic hydrogels with controlled aqueous fluid absorption” and published on Mar. 30, 2006, as U.S. Patent Publication No. 2006/0068014 A1 discloses cross-linked plasticized polymeric hydrogels suitable for use in skin contacting applications that can be used in association with medical, health and personal care products such as passive drug delivery devices and wound dressings.
U.S. patent application Ser. No. 13/054,208 entitled “Compositions for use as or in wound dressings” and published on Aug. 4, 2011, as U.S. Patent Publication No. 2011/0190722 A1 discloses a composition for the treatment of a wound wherein the composition comprises a first layer, which comprises a porous, optionally hydrophilic material capable of absorbing fluid from the wound at least in part by capillary action, and a second layer comprising an absorbent hydrogel. The first layer is associated with the second layer, and, in the treatment, the first layer is disposed closer to the wound than the second layer.
U.S. patent application Ser. No. 11/840,536 entitled “Absorbent materials and articles” and published on Dec. 6, 2007, as U.S. Patent Publication No. 2007/0282237 A1 discloses an absorbent material that comprises a flexible, skin-conformable, moisture-absorbent sheet member, optionally a net member in sheet form overlying and associated with the absorbent sheet member on at least one face thereof, and a hydrogel disposed on at least one of the net member, when present.
A number of other patents teach various types of related dressings, including U.S. Pat. No. 4,324,237 to Buttaravoli; U.S. Pat. No. 5,571,079 to Bello et al.; U.S. Pat. No. 5,686,096 to Khan; U.S. Pat. No. 6,765,122 to Stout; U.S. Pat. No. 7,137.968 to Burell; and U.S. Pat. No. 7,858,838 to Holm et al. A number of other patents teach various single slit embodiments, such as U.S. Pat. Nos. 4,915,694; 5,554,106; 5,620,419; 5,968,000; 6,765,122; and 7,723,559. Other related references include U.S. Pat. No. 6,787,682 entitled “Absorbent foam wound dressing” and issued to Gilman; U.S. Pat. No. 6,124,521 entitled “Dermal wound window dressing securement system” and issued to Roberts; and U.S. Pat. No. 6,884,920 entitled “Hydrocolloid window catheter dressing and a method for making and using the same” and issued to Worthley.
There is a need, however, to provide an improved exudates absorbing device for complete or 360 degree or complete circumferential protection of a wound or percutaneous or drug delivery device insertion site. It is an object of the present invention to provide wound dressing device having transparency for inspecting the conditions of the wound or skin penetration site and absorbency to wick away blood and exudates to prevent maceration of the skin and the reduction in the transparency to the wound site. It is another object of the present invention to provide a dressing device having a transparent hydrogel center and an absorbent material to wick away blood and remove exudates wherein the hydrogel center can optionally comprise a bioactive agent to deliver antimicrobial and/or other wound healing factors at the wound site or site of the insertion of a percutaneous or drug delivery device into the body.
These and other objects of the present invention will be apparent from the following description and appended claims, and from practice of the invention.